Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.
| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote: "All eligible patients were randomly assigned to a random number
allocated from a random number sequence generated by a
computer, which excluded potential influence from treating physicians, to one of three treatment groups: RBV+IFN-a, LPV/ r+IFN-a, and RBV+LPV/r+IFN-a, with an allocation ratio of 1:1:1, and a block size of nine patients each."
Following contact with authors: "The randomization sequence was triggered by the investigator entering all participant concealed until interventions were assigned, after which participants and investigators were not masked to treatment. Laboratory staff performing quantitative or qualitative testing were blinded to treatment allocation, while medical staff were not blinded". Comment: Allocation sequence was generated randomly and concealed. |
| Deviations from intervention |
Low |
Comment: Unblinded study.
No patient cross-over. Administration of co-interventions of interest, antivirals, biologics and corticosteroids were reported. Co-interventions were balanced across arms Data were analyzed using intention-to-treat analysis |
| Missing outcome data |
Low |
Comment: 101 patients randomized; 101 patients analyzed.
Risk assessed to be low for the outcomes: Mortality. Incidence of viral negative conversion. Time to Viral Negative Conversion. WHO score 6 and above. WHO score 7 and above. Adverse events. Serious adverse events. |
| Measurement of the outcome |
Some concerns |
Comment: Unblinded study.
Mortality and viral negative conversion are observer-reported outcomes not involving judgement. WHO Score 7 and above reflects decisions made by the intervention provider. However, we consider that the assessment of these outcomes cannot possibly be influenced by knowledge of the intervention assignment. Risk assessed to be low for the outcomes: Mortality. Time to Viral Negative Conversion. Viral Negative Conversion events. WHO score 7 and above. For WHO score 6 and above, although the assessment could possibly be influenced by knowledge of the intervention assignment, we did not consider this likely to have happened in the context of a pandemic. Adverse events and serious adverse events may contain both clinically- and laboratory-detected outcomes, therefore it can be influenced by knowledge of the intervention assignment, but is not likely to. Risk assessed to be some concerns for the outcome: WHO score 6 and above. Adverse events. Serious adverse events. |
| Selection of the reported results |
Low |
Comment: Protocol and statistical plan available. Data analysed and presented according to a pre-specified plan. Risk assessed to be low for the outcomes: Mortality, Incidence of viral negative conversion, Time to viral negative conversion, WHO score 6 and above, WHO score 7 and above, Adverse events and Serious adverse events. |
| Overall risk of bias |
Some concerns |